FDA.reportPublic FDA data

Finefra Kids Tooth

Manufacturer
Jewoo Medical Co,.Ltd | Korea Life Science Co.,ltd
Effective date
2019-12-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:02:19

Label at a glance#

ProductFinefra Kids Tooth
Active ingredientSILICON DIOXIDE, ALCLOXA
Label structure8 sections

Indications and uses

Uses: Aids in the prevention of cavities, plaque, and gingivitis.

Dosage and administration

Directions: children 2 yrs. older: Brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician.: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. Children under 2 yrs.: Ask a dentist or physician

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Silica 13.00%, Alcloxa 0.16%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Sorbitol, Water, Glycerin, Sodium Cocoyl Glutamate, Stevioside, Flavor, Cellulose Gum, Xylitol, Charcoal Powder, Glycyrrhiza Glabra (Licorice) Root Extract, Aloe Barbadensis Leaf Extract, Gentiana Lutea Root Extract, Lavandula Angustifolia (Lavender) Flower Extract, Camellia Sinensis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Chitosan, Chamomilla Recutita (Matricaria) Flower Extract, Propolis Extract, Scutellaria Baicalensis Root Extract, Mika, Commiphora Myrrha Oil, Krameria Triandra Root Extract, Chamaecyparis Obtusa Oil, Eucalyptus Globulus Leaf Oil

PURPOSE

OTC - PURPOSE SECTION

Purpose: Anticavity

WARNINGS

WARNINGS SECTION

Warnings:

If you accidentally swallow more than used for brushing, Seek professional help or contact a poison control center immediately.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Uses

INDICATIONS & USAGE SECTION

Uses:

Aids in the prevention of cavities, plaque, and gingivitis.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:

children 2 yrs. older: Brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician.: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. Children under 2 yrs.: Ask a dentist or physician

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809328353797GTIN-13: 8809328353797
EAN-13: 8809328353797
GTIN storage (14 digits): 08809328353797		kids carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69653-120-022022-07-29C16284748780-1e4f33bdf-9e7b-d8a0-e053-dadaa90a6e4e9c72338f-c4e0-4c3a-8361-9e2bdcff0c98

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69653-120-01Finefra Kids Tooth70 g in 1 TUBEPASTE, DENTIFRICE701
69653-120-02Finefra Kids Tooth1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69653-120FINEFRA KIDS TOOTH (SILICON DIOXIDE, ALCLOXA) PASTE, DENTIFRICE [JEWOO MEDICAL CO,.LTD]1Legacy NDC, 2 package rows20191226_9c72338f-c4e0-4c3a-8361-9e2bdcff0c98.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69653-12069653-120-01, 69653-120-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4ACTIB
ALCLOXA18B8O9DQA2ACTIB
SORBITOL506T60A25RIACT
Water059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
67525822-1f74-4a64-b66e-1f81b97ea0589c72338f-c4e0-4c3a-8361-9e2bdcff0c982019-12-26WarningsExact identifier
spl id: 67525822-1f74-4a64-b66e-1f81b97ea058
spl set id: 9c72338f-c4e0-4c3a-8361-9e2bdcff0c98

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.